Nadifloxacin

Bacterial skin infection is a common clinical infectious disease, which is prone to recurrence and drug resistance, bringing obvious distress to patients' lives. Nadifloxacin, as a third-generation quinolone antibacterial agent, exerts its antibacterial effect by inhibiting the activities of bacterial DNA gyrase and topoisomerase IV and blocking the process of bacterial DNA replication. It has strong antibacterial activity against Gram-positive bacteria such as *Cutibacterium acnes*, *Staphylococcus aureus* and *Staphylococcus epidermidis*, as well as some Gram-negative bacteria. It is mainly used clinically for the treatment of skin infections such as acne vulgaris, folliculitis and impetigo, and the applicable population covers adult and adolescent patients with skin infections. Due to low systemic absorption after local administration, the incidence of adverse reactions is low, and it has high clinical acceptance.

The global market size of nadifloxacin is approximately USD 120 million, with China's market accounting for more than 35%, and the compound annual growth rate in the past 3 years has reached 7.2%. The growth momentum mainly comes from the steady increase in the demand for dermatological antibacterial drugs. At present, generic drugs dominate the domestic market, and the consistency evaluation of external preparations is advancing rapidly. Three enterprises have already passed the consistency evaluation for their nadifloxacin creams. The price adjustment related to centralized procurement at public medical institutions has further promoted the product penetration rate, and the supply and demand of upstream API have been released simultaneously.

The original developer of nadifloxacin is Otsuka Pharmaceutical Co., Ltd. of Japan, with the original brand name "Nadifloxacin". The core compound patent of nadifloxacin expired in Japan in 2003, and the compound patent in China has also expired. The main dosage form approved for the original product is cream, with the specification of 10g:0.1g. The original cream has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, 6 enterprises have completed the registration of nadifloxacin API in CDE with the status of A, and another 2 enterprises have the registration status of I. A number of nadifloxacin cream preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for nadifloxacin API to meet the needs of impurity qualitative and quantitative research in different R&D stages. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for relevant enterprises in the R&D and quality control links of APIs and preparations.